BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME

    MDR report key: 936432 · Received April 13, 2007

    Report

    Report Number
    6000048-2007-00137
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Report Date
    February 22, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE RETURNED REVEALED THAT THE DEVICE HAS BEEN USED, THE CUTTING WIRE IS BROKEN, AND THE WIRE'S ENDS WERE MELTED. A FULL FUNCTIONAL CHECK OF THE RETURNED DEVICE IS NOT POSSIBLE DUE TO THE BROKEN AND BENT CUTTING WIRE, HOWEVER, THE INTACT SECTION OF THE CUTTING WIRES MOVE WITHIN THE EXTRUSION WHEN THE HANDLE IS FUNCTIONED. THE ROOT CAUSE OF THE FAILURE IS UNK. CAP WAS OPENED TO ADDRESS THIS ISSUE. THE DIRECTIONS FOR USE IS BEING CHANGED TO EMPHASIZE THE IMPORTANT OF POSITIONING, TO CAUTION THE USER ON THE POTENTIAL HAZARD OF IMPROPER POSITIONING OF THE CUTTING WIRE, AND TO USE THE GENERATOR'S RECOMMENDED SETTINGS. THIS IS EXPECTED TO BE COMPLETED BY MAY 30, 2007. SINCE THE LOT NUMBER IS UNK, BSC CONDUCTED A SHIP HISTORY WHICH REVEALED THE LAST THREE LOT NUMBERS SHIPPED TO THIS CUSTOMER FOR THIS PRODUCT: 9289095, 9067007, AND 8952236. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE PERTINENT LOTS; LOT 9067007 AND 8952236 EACH HAD ONE SCRAP (BAD WELD/BROKE/TIGHT/NOT ASSEMBLED CORRECTLY) NOT RELATED TO THIS COMPLAINT. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR ANY OF THE THREE LOTS IDENTIFIED IN THE SHIP HISTORY. THE FEBRUARY 2007 15-MONTH COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED. AN UNFAVORABLE TREND WAS NOTED; HOWEVER, NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT. AN UNFAVORABLE TREND IS DEFINED AS TWO CONSECUTIVE INCREASING DATA POINTS. THE TREND REPORT REVEALS 13 COMPLAINTS REPORTED IN THE MONTH OF DECEMBER, 15 COMPLAINTS REPORTED IN THE MONTH OF JANUARY, AND 24 COMPLAINTS REPORTED IN THE MONTH OF FEBRUARY. CAPA IS ADDRESSING THIS TREND.

    Description of Event or Problem · 1

    NOTE 1: THIS MEDWATCH REPORT IS BEING SUBMITTED AS A RESULT OF RETURNED DEVICE EVALUATION. NOTE 2: THE DATE OF EVENT IS UNKNOWN. ON FEBRUARY 22, 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (PT AGE AND GENDER UNK), THE "TIP OF THE WIRE BROKE OFF DURING SPHINCTEROTOMY"; HOWEVER, FOLLOW-UP WITH THE BSC SALES REP INDICATED THAT "THE TIP DID NOT DETACH FROM THE DEVICE". THE DEVICE WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THE PT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME KNS KNS BOSTON SCIENTIFIC M00545170 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR